Government proposes immediate suspension of manufacturing licences of substandard drugs

Learn the stated distinction and keep the two meanings separate. NEW DELHI The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, to immediately suspend the manufacturing licences of drugs declared Not of Standard Quality (NSQ) on specified critical quality parameters. To address this regulatory concern, the Ministry has proposed a provision for immediate suspension of the manufacturing licence of the drug by the Central Licensing Approving Authority or the State Licensing Authority upon receipt of a government analyst’s report declaring the drug as NSQ with respect to assay, dissolution, related substances, impurities or sterility.

Check the reported status and any stated limitations; do not assume an outcome beyond the source.

Use the stated distinction to avoid mixing up different meanings. This may result in a time gap between the declaration of a drug as NSQ and the initiation of regulatory action. During this period, the drug may remain in circulation, posing potential risks to public health and making effective recall more challenging.

• NEW DELHI The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, to immediately suspend the manufacturing licences of drugs declared Not of Standard Quality (NSQ) on specified critical quality parameters. • The suspension shall continue until the manufacturer undertakes an effective root cause analysis to identify the reasons for the quality failure and implements appropriate Corrective and Preventive Action (CAPA) to the satisfaction of the licensing authority. • The amendments are expected to strengthen post-marketing regulatory surveillance, facilitate timely action against substandard medicines, promote greater accountability among manufacturers and marketers, and reinforce public confidence in the quality of medicines available in the country.